Bilateral Cochlear Implantation in Children With the MED-EL Cochlear Implant

Inclusion Criteria

• •Between 12 and 36 months of age at time of implantation
• •Profound bilateral sensorineural hearing loss
• •English as the primary language in the home
• •Realistic expectations of guardians
• •Child must be enrolled in a post-operative rehabilitative/educational program that supports the use of cochlear implants and the development of auditory-based skills
• •Willing and available to comply with all scheduled procedures as defined in the protocol
• •Audiological:
• •Profound bilateral sensorineural hearing loss with average thresholds between ears of 90 dB HL or greater at 1000 Hz and above, and must demonstrate minimal functional benefit from conventional amplification
• •Behavioral test measures must include unaided threshold measures for the right and left ears using insert earphones; left-alone and right-alone aided sound field threshold measurements; and aided and unaided speech-awareness / detection thresholds (for each ear individually)
• •Children accepted into the study must be able to demonstrate a consistent response to sound. If a child has no measurable hearing, he/she must be able to demonstrate a consistent response to vibrotactile stimuli.
• •All children must have completed an appropriate trial period with optimally fit amplification prior to inclusion in the study.
• •Medical:
• •Good general health status, as judged by Primary Investigator
• •Patent cochleae bilaterally, as indicated by radiological evaluation
• •No contraindications for surgery, in general, or cochlear implant surgery in particular